Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324220
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2006-05-08
Brief Title:
A Phase III Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome MDS or Acute Myelogenous Leukemia
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase III Study of MGCD0103 MG-0103 in Combination With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study MGCD0103 a new anticancer drug under investigation is given three times weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes or acute myelogenous leukemia
Detailed Description:
Phase I The purpose of the first part Phase 1 of this study is to find out what side effects the experimental drug MG-0103 in combination with azacitidine has on your body The first part or Phase of the study will find out how much MG-0103 can be given safely along with azacitidine to people with cancer without causing side effects that are too severe Patients are given MG-0103 and azacitidine and are watched closely to see what side effects may develop and to make sure that if side effects are seen they can be taken care of rapidly If the side effects are not severe then more patients are asked to join the study and are given the same or a slightly higher dose of MG-0103 If there are no severe side effects patients joining the study later on will get higher doses of MG-0103 than patients who join earlier All patients will get the same dose of azacitidine This will continue until a dose of MG-0103 is found that causes severe side effects in a high enough portion of patients This will be the maximum dose of MG-0103 that can be given to patients in this study Doses higher than that will not be given Additional patients may be asked to join the study and receive MG-0103 and possibly azacitidine at lower doses that did not cause severe side effects
Phase II MG-0103 in combination with azacitidine may also have some effect on your disease The purpose of the second part Phase 2 of this study is to find out what if any effect there is This Phase of the study will also find out more information about side effects of this combination of drugs In this Phase patients will receive a slightly lower dose than the maximum dose found in the first part of the study which causes tolerable side effects If a certain effect on the disease of patients is seen then more patients are asked to join the study Additional patients may also be asked to join the study and receive a lower dose if information collected during the study suggests that this should be done
Phase II MG-0103 in combination with azacitidine may also have some effect on your disease The purpose of the second part Phase 2 of this study is to find out what if any effect there is This Phase of the study will also find out more information about side effects of this combination of drugs In this Phase patients will receive a slightly lower dose than the maximum dose found in the first part of the study which causes tolerable side effects If a certain effect on the disease of patients is seen then more patients are asked to join the study Additional patients may also be asked to join the study and receive a lower dose if information collected during the study suggests that this should be done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None